Repurposed technology to help sterilize millions of N95 respirators for health care workers

Millions of N95 respirators used by U.S. health care workers in hospital settings can now be sterilized for reuse, helping to combat the spread of COVID-19.

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) on April 11 for one such technology that has the potential to decontaminate 4 million respirators, or masks, per day in this country.

Advanced Sterilization Products (ASP) develops STERRAD System Sterilizers, a portfolio of technologies that many hospitals in the United States already possess to sterilize nearly 25,000 types of medical equipment. The STERRAD technology utilizes a low-heat environment to avoid damaging masks during sterilization, as vaporized hydrogen peroxide gas plasma is applied. This isn’t a new technology or chemical application for this series of machines, only a new usage.

“We work with mask manufacturers from around the world,” said Dominic Ivankovich, president of Advanced Sterilization Products, whose firm has gone through similar emergency use authorizations in Canada, Japan, and the European Union. “Eventually the mask manufacturers and supply chains will catch up to the needs of the market and health care workers, but in the short run that’s not really possible.”

What is possible, says Ivankovich, is that STERRAD can sterilize N95 respirators for two reprocessing cycles, allowing the masks to be worn three times, addressing the need for more personal protective equipment (PPE). The technology can process approximately 480 masks per day for a typical urban hospital. There are approximately 9,930 STERRAD sterilization systems in approximately 6,300 hospitals across the United States.

Advanced Sterilization Products also is exploring the feasibility of sterilizing other PPEs such as medical gowns.

FDA Commissioner Stephen M. Hahn said in a written statement that, “This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.”

Hahn added that the nation must do everything it can to increase the availability of critical medical devices that health care workers need, like N95 respirators.

“At the end of the day,” Ivankovich said, “we’re really doing it for people on the front lines, and all of us are driven to do whatever we can to make that job safer and more effective.”